UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021591 |
|---|---|
| Receipt number | R000024894 |
| Scientific Title | The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2021/09/28 11:56:25 |
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Basic information
Public title
The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Acronym
The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Scientific Title
The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Scientific Title:Acronym
The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of nintedanib and carboplatin plus paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of treatment-related ILD
Key secondary outcomes
RR: response rate
OS: overall survival
PFS: progression free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carboplatin AUC6 D1
paclitaxel 200mg/m D1
tryweekly 4cycle
nintedanib 150mg twice daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed non-small-cell lung cancer
2) stage3B, stage4 or postoperative recurrence NSCLC
3) Idiopathic interstitial pneumonia
4) performance status 0 or 1
5) Age>=20
6) Measurable lesion
7) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=1500/mm3
Hgb>=9.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<2.5*ULN
ALT=<2.5*ULN, CRN=<1.5*ULN
PaO2>=60.0 torr or SpO2>=93.0 %
8) Life expectancy > 8 weeks
9) Written informed consent
Key exclusion criteria
1)Uncotrollable angiona pectorias, cardian infarction, haear failure, diabetes mellitus, hypertension
2) Using prednisolone >10mg/day
3) Active infection
4) Active double cancers
5) symptomatic brain metastasis
6) Patients with uncontrolled pleural or pericardial effusion, or ascites
7) pregnancy
8) Patient with a history of allergy to CBDCA, PTX and nintedanib
9) Inappropriate patients in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | sadatomo |
| Middle name | |
| Last name | Tasaka |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
0368562
Address
Zaifu-cho 5, Hirosaki, Japan
TEL
0172395468
xyghx335@gmail.com
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Tanaka |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
0368056
Address
Zaifu-cho 5, Hirosaki, Japan
TEL
+81-172-33-5111
Homepage URL
xyghx335@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Hirosaki
Address
5 zaifucho Hirosaki Japan
Tel
0172335111
rinri@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
弘前大学医学部附属病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024894
